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TEST METHOD VALIDATION Randall J. Troutman CPP Senior ...

TEST METHOD VALIDATION Randall J. Troutman CPP Senior ...

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uggedness (robustness)<br />

Definitions<br />

determination of variables associated with the performance of a test<br />

method that is ultimately critical to the accuracy of the precision<br />

statistical control<br />

point when the test results obtained vary in a predictable manner,<br />

showing no unassignable trends, cycles, abrupt changes, excess<br />

scatter, or other unpredictable variations as determined by<br />

application of appropriate statistical methods

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